Protocol Administration Set with Small Catheter and Retention Cuff 390402

GUDID 30815112021284

Protocol Administration Set with Small Catheter and Retention Cuff CO2 Delivery System for Colon Insufflation

BRACCO DIAGNOSTICS INC

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• Primary Device ID: 30815112021284
• NIH Device Record Key: 3993f4cd-4f02-47d1-8d14-53ee9d541862
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Protocol Administration Set with Small Catheter and Retention Cuff
• Version Model Number: 390402
• Catalog Number: 390402
• Company DUNS: 849234661
• Company Name: BRACCO DIAGNOSTICS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx

Device Dimensions

• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815112021280 [Primary]
GS1	30815112021284 [Package]; Contains: 10815112021280; Package: Box [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030854

FDA Product Code

• FCX: Insufflator, Automatic Carbon-Dioxide For Endoscope

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-07
• Device Publish Date: 2023-06-29

On-Brand Devices [Protocol Administration Set with Small Catheter and Retention Cuff]

• 30815112020171: Protocol Administration Set with Small Catheter and Retention Cuff CO2 Delivery System for Colon
• 30815112021284: Protocol Administration Set with Small Catheter and Retention Cuff CO2 Delivery System for Colon